Institutional Membership Application

ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY INSTITUTIONAL MEMBERSHIP APPLICATION

Your complete application package must include the following documents:

Cover Letter from the Principal Investigator of the Main Member (see instructions for additional information)

Completed Membership Application

Federalwide Assurance Application/Documentation

NIH Bio-Sketch/CV (for Principal Investigator only)

List of Investigators and Specialties

List of Affiliate Sites (if applicable)

Copy of Audit Reports and Corrective Action Plans

(If application is incomplete, it will not be submitted to the Membership Committee)

Revised June 14, 2012 1 ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY INSTITUTIONAL MEMBERSHIP APPLICATION

Membership Application Type: Main Affiliate

Institutional Information Legal Name of Institution: (Confirm the legal name with an institution official. This should match the NCI ID Code, if assigned)

Legal Address of Institution:

NCI Identification Code:

Name of Principal Investigator: Phone: E-Mail: Name of Co-Principal Investigator (required for main member): Phone: E-Mail: Name of Lead CRA: Phone: E-Mail: Name of Institutional Official (contact for legal agreements): Phone: E-Mail:

FWA and IRB Information Federalwide Assurance #: Expiration Date: (If you do not have an FWA #, this application will not be processed) Name and address of Institutional Review Board:

IRB Registration Code Number: Expiration Date: (Applications will be delayed until this information is provided, as this is a NIH requirement)

Funding Information Does a Community Clinical Oncology Program (CCOP) Grant currently fund your institution/group? Yes  No If “yes," indicate the grant number and funding period. Grant #: Funding Period: If you are applying for a CCOP grant, please indicate your application submission date (mm/dd/yy).

MEMBERSHIP PROPOSAL

1. Indicate the resources available to assure timely compliance with Group administrative and data requirements (please mark all that apply).

Role Number of Personnel Comments Investigators Clinical Research Associates/Professionals Oncology Nurses Regulatory Support Pharmacy Personnel

2. Have you participated in cancer research cooperative group trials? Yes No

If yes, . List the group(s):

 Provide a copy of the most recent CTMB audit report(s). If applicable, please include the corresponding corrective action plan(s).

 Provide the total number of cancer patients enrolled onto all cooperative group clinical trials per year. ______(3 year average)

3. Have you participated in non-cooperative group cancer research trials? Yes No

If yes, provide the number of cancer patients enrolled onto non-cooperative group clinical trials per year. ______(3 year average)

If you have not enrolled patients on cooperative group clinical trials, complete items 4 and 5. Provide the details for the disease (s) or committee (s) appropriate to your Institution.

4. Document adequate patient resources available for entry into clinical trials. List your annual caseload by hospital and by disease.

Breast Cancer GI GU Leukemia Lymphoma Myeloma Neurologic Respirator Control y

5. Indicate anticipated accrual by types of studies (by disease or committee). You may wish to consult a recent studies list, which shows the current studies by committee, so you can make accurate accrual projections. This list is on the Alliance web page or available upon request.

Breast Cancer GI GU Leukemia Lymphoma Myeloma Neurologic Respiratory Control

Specify any disease areas (or committees) of Alliance research in which you do NOT foresee participation.

MEMBERSHIP PROPOSAL INSTITUTIONAL MEMBERSHIP INVESTIGATOR ROSTER INFORMATION

Complete the table below for each Investigator to be included on your roster

Name Specialty Discipline

MEMBERSHIP PROPOSAL

AFFILIATE SITES

(For Main Member Applicants Only) List all sites that meet at least one of the following.  Direct receipt of agent from CTEP;  Enrollment or consent of patients;  Direct receipt of federal funds; and/or  Responsible for submission of data to the study sponsor or their designee

NCI Legal (Full) Name of Principal Co-principal Address (must match Code Affiliate Institution Investigator investigator (if address for NCI Code, (should match NCI ID applicable) if assigned) Code)

Submit a separate Alliance Membership Application and Cover Letter for each site listed.

MEMBERSHIP PROPOSAL

Application submitted by on:

Signature of Proposed Principal Investigator date

Signature of Institution Official date

Return Completed Application to: Membership Manager Marcia Kelly 230 W. Monroe Street Suite 2050 Chicago, IL 60606 [email protected] 773-834-7676

Revised June 14, 2012 7